Monday, December 15, 2014
Ebola demands our full attention
The cheery and
intelligent man who operates our local dry cleaning agency and I often chat. He
has a son doing medicine, and last week, he was worried about Ebola.
He feared that casual
contact in his shop or, in the case of his son, on the wards might lead to the
disease.
It made me realise
that it is easy to overestimate community understanding of the basic facts
about Ebola.
Not that as health
professionals we know all there is to know about it - even the precise details
of its transmission are uncertain - but sharing what we do know can help the
public manage its anxiety.
And quality vigilance
depends on good intelligence. So what do we know? The first good thing - and
there are not many - is that over half the people who contract it recover.
It is less certain how
recovery occurs and whether classic principles of immunity apply, but a 50%
recovery rate is a lot better than we saw with HIV in the early years.
Medical care also
helps. Fluid replacement and intensive care make a difference to survival
chances.
Second, the disease
thus far appears to spread through blood, sweat and other body fluids,
especially the excreta of infected people, to those who touch them during life
or death. Airborne transmission has not been documented.
In theory, this means
that enhanced infection control procedures can protect family and health
professionals.
However, as of the end
of October, about 500 healthcare workers had contracted Ebola and half of them
had died, so protection as practised at present is far from perfect.
Third, we live in an
age of brilliant technological possibility, so the search for a drug to treat
Ebola or a vaccine to prevent it is likely to yield dividends quickly.
The most likely
limits, with so few cases, will be political and economic, as the cost of
developing a drug or vaccine may not be a good commercial deal. But the
accolades that would come to the inventor of a drug or vaccine would be great.
Furthermore,
technological fixes are not always expensive. As reported in the 27 October
issue of the New Yorker, a recent competition run by Columbia University
yielded several inexpensive innovations designed to assist in managing Ebola.
The competition,
auspiced by the schools of public health, and engineering and applied sciences,
was open to all students and faculty. Among them was an inexpensive hose that
sprayed bleach foam rather than a solution, because unlike a bleach solution,
with foam you can see where it has been sprayed.
But there are
significant endemic barriers to combating the virus in West Africa.
The impoverishment of
the countries where Ebola has become an epidemic is a major limitation, both in
the treatment of those with the disease and the control of its spread.
Poverty means fewer
healthcare facilities and medical supplies, which is why the military support
offered by the US, with its sophisticated logistic capability, will make a huge
contribution.
Last month, 4000 US
troops with cargo planes stuffed with all necessary equipment and transport were
deployed to Monrovia in Liberia as part of Operation United Assistance.
With that as a
background, groups such as Médecins Sans Frontières and other NGOs' efforts
will be enhanced by field hospitals and supply lines for IV fluids and material
needed to care for Ebola patients.
Medical volunteers
from Australia are also contributing to the Ebola effort - including
supporting diagnostic laboratories that are hard-pressed to keep up in the
affected countries, and are working with MSF and the Red Cross on the front
line.
This month, the
Federal Government pledged $20 million in funds for the private healthcare
company Aspen Medical to operate a 100-bed hospital in Sierra Leone that will
be run by 240 healthcare staff, some of whom will be Australian.
The move came after
weeks of public accusations by the AMA and NGOs that the government was not
doing enough.
However, until
effective treatment and infection control measures are more widely implemented
in Africa, the course of the epidemic is hard to predict.
I understand that the
mutagenic potential of the Ebola virus is no match for influenza, but if its
mode of transmission does expand to include airborne routes, the challenge of
the epidemic would grow enormously.
Figures published by
the US Centers for Disease Control and Prevention say almost 5000 people in
West Africa have died from the virus, with the number of cases in Sierra Leone
and Liberia said to be doubling every 20 days, which means that by year's end,
those affected will be approaching 1.4 million.
It is clear Ebola
deserves our serious attention: just as we view the extremist Islamic State as
a distant threat to Australian security, so too we should view
Ebola.
As for my friend the
dry cleaner, when he asked if he should wash his hands after handling
unfamiliar garments, my cautious (but not entirely rational) answer was, yes.
Professor Leeder is a member of the Menzies
Centre for Health Policy at the University of Sydney, chair of the Western
Sydney Local Health District Board and editor-in-chief of the Medical Journal
of Australia.
Published in Australian Doctor 17 November, 2014 http://bit.ly/16p4FTz
Stronger focus on drug side effects needed
Randomised controlled
trials are the supreme method for determining whether a new treatment,
frequently a new pharmaceutical, is superior to current best practice.
They were originally
used in agriculture to assess the added value of a new plant or soil additive,
but are now firmly ingrained in medical practice.
I recall 30 years ago,
an eminent professor of surgery railing against randomised controlled trials,
which he considered utterly inappropriate to determine the value of surgical
interventions.
He wrote a scathing
article in which he referred repeatedly and disparagingly to such trials as
"agricultural statistics".
While the randomised
controlled trial has given us the best possible evidence about the effects of
new therapies for a range of conditions, especially cancer and cardiovascular
disease, and have underpinned the evidence-based medicine movement, they do not
cover the entire treatment waterfront. This is especially so in relation to
side effects.
The way randomised
controlled trials work is that they aim to find out how many patients need to
be treated — either with the new therapy or the old — to determine if the new
drug is better.
The expected
improvement in cancer trials is small, usually less than 10%, and so these
studies require larger numbers of patients to be sure that even the slightest
difference in outcome can be seen.
Sample size
calculations, therefore, are based on the detection of relatively rare events,
such as a gain in life expectancy or quality of life.
But side effects are
another matter. They often fall beyond the vision of the trial, or out of focus
of its carefully calculated sample size.
Side effects may not
occur for months or years after a trial has finished, or they may be so rare
that the randomised controlled trial's sample size is insufficient to detect
them, even if they occur during the trial.
With some medications,
side effects are of huge importance — for example, if the trial is testing a
preventive intervention such as immunisation, rather than a treatment for a
serious illness where side effects may be tolerated.
Nobody wants to enter
a trial feeling whole and well and leave it with a nasty side effect.
Publicity around
claims of side effects from immunisation illustrate this point, and show how
critical it is to be secure about the proposed preventive interventions.
Similar concerns
surround trials of cholesterol-lowering drugs in very low-risk populations.
Side effects can be hard to detect, and if the treated trial subjects are at
low risk of the disease (such as an MI) that the drug is intended to reduce but
then develop problems with, for example, muscle power, a hard-to-resolve
problem arises. Witness the controversy around the Catalyst TV programs
on exactly this topic.
So there is a sizeable
challenge to be sure that we know what side effects occur, and brilliant
randomised controlled trials will not necessarily tell us about rare and
distant ones.
Currently, especially
in the case of new drugs, the pharmaceutical company sponsoring the trial will
have given serious thought to this matter and have in place systems to collect
information about side effects.
Of course, it is not
only in the context of randomised controlled trials that side effects occur and
old remedies, especially in specific genetic subsets of the population, may
cause rare problems. Often more information, especially long-term data, is
needed.
An intelligence system
to learn about possible side effects is far more feasible today than even 10
years ago.
The high degree of
electronic connectivity that we all enjoy (and sometimes loathe) can put us in
touch with agencies, such as the TGA, to report possible side effects at the
click of a mouse.
Now the TGA has come
up with an online reporting system for patients as it's concerned that the vast majority of
side effects go unreported. Doctors report some and drug companies others, but
for over-the-counter and alternative medicines, there have been no formal
reporting pathways.
The TGA may easily be
overwhelmed with side effect noise and it will need a good filtering system to
detect the signals. But this is surely a move in the right direction; another
step to ensure medication safety as well as efficacy as we continue to advance
our capacity to prevent and to treat.
Professor Leeder is a member of the Menzies
Centre for Health Policy at the University of Sydney, chair of the Western
Sydney Local Health District Board and editor-in-chief of the Medical Journal of Australia.
Published in Australian Doctor 8 October 2014 http://bit.ly/1BRzk91
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